The present disclosure relates generally to medical fluid access devices for the addition or withdrawal of fluid to or from medical fluid flow systems. More particularly, the present disclosure generally relates to medical fluid access devices including an indicator which indicates proper aseptic technique and methods of making and using the same.
Medical access devices are commonly used in association with medical fluid and vial containers and medical fluid flow systems that are connected to patients or other subjects undergoing diagnostic, therapeutic or other medical procedures. The access devices simplify the addition of fluids to or withdrawal of fluids from the container or the fluid flow system.
Within the medical field there are a wide variety of medical fluid flow systems, serving a variety of functions. One of the more common fluid flow systems is used for infusion therapy or the intravenous administration of fluids contained in a syringe or container, such as saline, antibiotics, or any number of other medically-related fluids, to a patient. These flow systems commonly include intravenous or “IV” fluid administration sets and catheters, and use polymeric tubing to fluidly connect a phlebotomized subject to one or more medical fluid sources, such as intravenous solution or medicament containers. Infusion therapy may also include vials which are accessed for withdrawal of pharmaceutical substances and subsequent administration to the subject.
Typically, such intravenous administration sets include one or more access devices providing access to the fluid flow path to allow fluid to be added to or withdrawn from the IV tubing. For example, an access device may allow for the introduction of medication, antibiotics, chemotherapeutic agents, or a myriad of other fluids to a previously established IV fluid flow system. Such administration sets are connected to a indwelling catheter through use of an access device which may or may not be similar in design to the access devices on the set. The access device may be used for withdrawing fluid from the subject for testing or other purposes, for example drawing the fluid from the patient via the catheter. Retaining an indwelling catheter in a patient eliminates the need for phlebotomizing the subject repeatedly and allows for immediate administration of medication or other fluids directly into the subject.
Several different types of access devices are well known in the medical field. Although varying in the details of their construction, these devices usually include an access site for introduction or withdrawal of medical fluids through the access device. For instance, such devices can include a housing that defines an access opening for the introduction or withdrawal of medical fluids through the housing, and a resilient valve member or gland that normally closes the access site. Beyond those common features, the design of access sites varies considerably. For example, the valve member may be a solid rubber or latex septum or be made of other elastomeric material that is pierceable by a needle, so that fluid can be injected into or withdrawn from the access device. Alternatively, the valve member may comprise a septum or the like with a preformed but normally closed aperture or slit that is adapted to receive a specially designed blunt cannula therethrough. Other types of access devices are designed for use with connecting apparatus employing standard male luers. Such an access device is commonly referred to as a “luer access device” or “luer-activated device,” or “LAD.” LADS of various forms or designs are illustrated in U.S. Pat. Nos. 6,682,509, 6,669,681, 6,039,302, 5,782,816, 5,730,418, 5,360,413, and 5,242,432, and U.S. Patent Application Publications Nos. 2003/0208165 and 2003/0141477, all of which are hereby incorporated by reference herein.
Access devices may also be fashioned as a part of a larger device or structure. For example, stop-cocks or the like used in medical fluid flow control may include access ports normally closed by septums or other elastomeric gland structures. Access devices or access sites may also be part of containers, such as vials or bags that have an opening closed by an elastomeric stopper or septum or other valve member.
Before an access device is actually used to introduce or withdraw liquid from a container or a medical fluid flow system or other structure or system, good medical practice or proper aseptic technique dictates that in close time proximity to the access of the site, the access site and surrounding area be contacted, usually by wiping or swabbing, with a disinfectant or sterilizing agent such as isopropyl alcohol or the like to remove or kill harmful bacteria or other pathogens and reduce the potential for contaminating the fluid flow path and harming the patient. It will be appreciated that a medical fluid flow system, such as an IV administration set and associated catheter, provides a direct avenue into a patient's vascular system. Without proper aseptic techniques by the physician, nurse or other clinician, microbes, bacteria or other pathogens found on the surface of the access device could be introduced into the IV tubing and/or catheter and thus into the patient when fluid is introduced into or withdrawn through the access device. Accordingly, care is required to assure that the healthcare practitioner uses proper aseptic techniques when the access devices are utilized for the injection or withdrawal of substances during infusion therapy such as from the container, vial, catheter or set.
Detection of the occurrence of proper aseptic technique may be problematic. Generally the wiping does not leave a residue that is detectable by the health care provider. For example the more common disinfectants are clear and their presence is not typically visually discernable. It may also be problematic to determine if the proper disinfectant was used for practicing the technique. For example wiping with water is generally not believed to be sufficient to disinfect the access device.
As described more fully below, the fluid access device of the present disclosure provides an important advance in the safe and efficient administration or withdrawal of medical fluids to or from a patient.